MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG DISCOFIX®; STOPCOCK

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 05/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received one used discofix-4 blau 2ver ms "hk" without packaging.The received sample was checked visually.On the received sample, the handle is detached from the discofix housing.Damages at the handle or at the housing which would lead to a slight dismantling of the handle were not detected.Afterwards the handle was fitted (via the snap fastening) into the housing.A slight loosening at the connection of the handle and the discofix housing was not detected on the sample.The sample was tested for liquid-tightness according to test plan.Nominal: liquid-tightness in all positions, no leakage of water by 200kpa /15min.(din en iso 8536-10).Actual: we detected no leaks at the complete system.Since we detected no damages or manufacturing fault on the sample, we can take the complaint only to our knowledge.We have informed our manufacturer accordingly.A follow-up report will be provided after the statement is available.

Event Description

As reported by the user facility ((b)(4)): three way tap of stopcock became detached leading to backflow of blood and leakage of approximately 200mls of blood.

• Brand Name: DISCOFIX®
• Type of Device: STOPCOCK
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5163368
• MDR Text Key: 28986157
• Report Number: 9610825-2015-00466
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K760383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2015,09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2017
• Device Model Number: N/A
• Device Catalogue Number: 16466
• Device Lot Number: 14MO992043
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2015
• Distributor Facility Aware Date: 10/20/2015
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2015
• Initial Date Manufacturer Received: 09/29/2015
• Initial Date FDA Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1